SYNERGY China: Assess SYNERGY Stent in China

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: SYNERGYTM Coronary Stent System

• Registration Number: NCT02499692
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.

Detailed Description

The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Study Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Primary Completion: 2015-10
• Results First Submitted: 2015-12-11
• Results First Submitted QC: 2015-12-11
• Results First Posted: 2016-01-18
• Study Completion: 2017-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Subject must be at least 18 -75 years of age
2. Subject is eligible for percutaneous coronary intervention (PCI)
3. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm, length must be ≤34* mm (by visual estimate), Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1

Key

Exclusion Criteria

1. Planned PCI (including staged procedures) or CABG after the index procedure
2. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
3. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
4. Planned treatment of more than 3 lesions, Planned treatment of lesions in more than 2 major epicardial vessels, Planned treatment of a single lesion with more than 1 stent
5. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
6. Target vessel develops a dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C following the pre-dilatation/pre-treatment of the first target lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYNERGYTM Coronary Stent System	SYNERGYTM Coronary Stent System	Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System

Primary Outcome Measures

Name	Time	Method
Technical Success Rate	1 day	Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

Secondary Outcome Measures

Name	Time	Method
Target Vessel Revascularization (TVR) Rate	30 days
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate	30 days
Target Lesion Revascularization (TLR) Rate	30 days
Target Lesion Failure (TLF) Rate	30 days
Target Vessel Failure (TVF) Rate	30 days

Trial Locations

Locations (8)

TEDA International Cardiovascular Hospital; 🇨🇳 Tianjin, China

AeroSpace center hospital; 🇨🇳 Beijing, China

Daqing General Oil Field Hospital; 🇨🇳 Daqing, China

the second hospital of Jilin Unversity; 🇨🇳 Changcun, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, China

General Hospital of SY Military Institute; 🇨🇳 Shenyang, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, China